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Food and Drug Administration (FDA) › Databases

Troutman Pepper

FDA Launches Legally Marketed Tobacco Products Database

Troutman Pepper on

FDA recently announced the launch of a new searchable database containing almost 17,000 tobacco products that may be legally marketed in the U.S. The database provides information on each tobacco product including product...more

BCLP

Supplemental Information on Dietary Supplements: Federal Proposal Aims to Establish Mandatory Dietary Supplement Database

BCLP on

In an aim to increase transparency in the U.S. dietary supplement industry, Senators Dick Durbin (D-IL) and Mike Braun (R-IN) recently introduced the Dietary Supplement Listing Act of 2022 - a bill that would require...more

Mintz - Health Care Viewpoints

FDA Greenlights Updates to the Purple Book Database

Mintz - Health Care Viewpoints on

As promised, the Food and Drug Administration (FDA) updated the Purple Book: Database of FDA-licensed Biological Products, providing greater transparency and more user-friendly search functionality for the biological product...more

Hogan Lovells

FDA finalizes guidances for NGS-based tests

Hogan Lovells on

On April 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests. Unlike most IVDs that typically detect...more

Searcy Denney Scarola Barnhart & Shipley

FDA Adverse-Event Reports Go Public

Searcy Denney Scarola Barnhart & Shipley on

Years of adverse-event reports documenting problems associated with compromised food, dangerous drugs and harmful cosmetics are now available to the public. The information can be obtained, free of charge, via a downloadable...more

Foley & Lardner LLP

FDA Issues Guidance on Use of Public Human Genetic Variant Databases and Their Use in Personalized Medicine

Foley & Lardner LLP on

Next Generation Sequencing (NGS) permits the analysis of millions of genetic variants at a time and has proven to be invaluable for the development of personalized or precision medicine. Analysis of whole genomes is providing...more

McDermott Will & Emery

FDA Aims to Expand Sentinel Capabilities, Include Evaluation of Drug Effectiveness

McDermott Will & Emery on

At a recent public workshop, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), announced plans to expand the agency’s use of the Sentinel...more

Mintz - Health Care Viewpoints

FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public

Mintz - Health Care Viewpoints on

Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and...more

Morrison & Foerster LLP

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

Morrison & Foerster LLP on

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

Patrick Malone & Associates P.C. | DC Injury...

Grand Opening of openFDA.gov

Patrick Malone & Associates P.C. | DC Injury... on

Information is power, and as of this month, there’s a new power source of information about drug effects. openFDA.gov is an initiative of the U.S. Food and Drug Administration to expand access to and use of reports of...more

Faegre Drinker Biddle & Reath LLP

FDA Launches Huge Online Database of Adverse Events

Faegre Drinker Biddle & Reath LLP on

As part of the Obama administration's effort to make public information more accessible, the FDA launched openFDA on June 2, 2014. This new database makes nearly 4 million pharmaceutical adverse event reports the FDA...more

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